MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV AXIUM PRIME BRPL HLX; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	APB-3-8-HX-ES
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis as found condition: the axium prime device was returned for analysis within a shipping box and within a sealed plastic biohazard pouch.The unknown echelon micro catheter used in the event was not returned for analysis.Visual inspection/damage location details: the pusher was found broken at the break indicator with the release wire retracted, typically indicative of a manual detachment attempt.No other damages were found with the pusher.The coin was found retracted out of the lumen stop, the shield coil was found undamaged, and the implant coil was already detached and not returned for analysis.Testing/analysis: the axium prime device could not be used for resistance testing as the implant was already detached.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in cath.Hub¿ and ¿coil resistance/stuck in catheter¿ could not be confirmed.Possible causes for coil resistance at catheter hub are, but not limited to, failure to hydrate the coil prior to use, failure to utilize continuous flush, micro catheter damage, or use of an improper hubbing technique (over tightening of the rhv/sheath not firmly seated into hub).The resistance would likely damage the implant, causing the reported resistance in catheter.The root cause could not be determined.The break indicator was found broken, the coin was retracted out the lumen stop, detaching the implant as expected by the detachment subassemblies.Customer did not report detaching the device.As the unknown echelon micro catheter used in the event was not returned for analysis, any contribution of the micro catheter towards the resistance could not be determined.All models of echelon micro catheters are compatible for use with this model of axium prime.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received a report that the guide catheter was passed to the working table, through which a 0.035 hydrophilic guidewire was advanced, reaching the common carotid artery.The guidewire was removed and the microcatheter was advanced.It was mounted on a 0.014 guidewire through the internal carotid artery.After performing angiographic acquisitions, measurements of the left internal carotid artery were taken.The physician requested an apb 3 x 8 cm helix coil.The device was purged with heparinized solution.The coil was advanced through the microcatheter, which did not advance.The physician requested another one.The coil was stuck in the catheter.There was no damage to the catheter.No patient symptoms or further complications were reported as a result of this event.There was no injury as a result of this event.This event did not lead to or extend patient hospitalization.There was no medical or surgical intervention needed to prevent a permanent impairment of a function.The device and any accessories were prepared as indicated in the ifu.The patient was undergoing surgery for treatment of a fusiform, unruptured aneurysm.It was noted the patient's blood flow was normal and vessel tortuosity was moderate.Ancillary devices include an echelon 45  microcatheter.Additional information received reported that the cause of the resistance was not determined.The resistance was in the hub and prox imal part of the catheter.A continuous saline flush administered and maintained as indicated in the ifu.

• Brand Name: AXIUM PRIME BRPL HLX
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 22246033
• Report Number: 9617601-2025-00550
• Device Sequence Number: 18539749
• Product Code: KRD
• UDI-Device Identifier: 00763000313975
• UDI-Public: 00763000313975
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K151447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: APB-3-8-HX-ES
• Device Catalogue Number: APB-3-8-HX-ES
• Device Lot Number: 229753204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Female